Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

The present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet, Hematology clinic, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult men and women with newly diagnosed acute myeloid leukemia

Exclusion criteria

under age 18 years

Treatment and study plan

PK-PD analysis

Other

The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.

Primary outcomes

significant covariates from the PK study

Time frame: after complete analysis of data

Secondary outcomes

Amount of the three drugs in patient plasma samples

Time frame: within 3 months of sampling

Sponsors and collaborators

Lead sponsor

Mikkel Krogh-Madsen

Other

Collaborators

Herlev Hospital
Rigshospitalet, Denmark

Registry information

Official study title

Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia

Important dates

Study start: 2009
Study completion: 2011
First posted: Sep 1, 2009
Registry last updated: Aug 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed